Renu with MoistureLoc MultiPurpose Contact Lens Solution

Renu MoistureLoc

The U.S. Food and Drug Administration (FDA) released a statement on Monday, May 15, 2006 announcing that Bausch & Lomb, makers of the ReNu with MoistureLoc contact lens cleaning solution product that has been linked to at least 32 confirmed cases of Fusarium keratitis infection in the United States, had recalled the product worldwide.

Due to a number of adverse event reports received by the FDA and the Centers for Disease Control (CDC), the FDA investigated a Bausch & Lomb facility in Greenville, SC, linked to cases of a fungal eye infection known as Fusarium keratitis, a rare bacterial infection, in the U.S., Singapore and Hong Kong. In its preliminary statement on its investigation, the FDA found 20 potential violations in the Greenville, SC, facility. Among the most serious findings in the report was the fact Bausch & Lomb did not report to the FDA or the CDC that 35 cases of Fusarium keratitis in Singapore were confirmed as being linked to their product within 35 days as required for products manufactured in the United States. The company had reports of problems as early as July 2005 but had not reported details to the FDA as of May 9, 2006.

The eye infection reported in these cases, a rare but extremely serious microbial keratitis caused by the fungus Fusarium, may cause personal injury and vision loss severe enough to require corneal transplants in affected individuals. Fusarium keratitis requires up to three months of treatment and may cause corneal scarring and permanent blindness.

As of April 27, over 200 cases of fungal keratitis have been reported to these federal agencies, with 73 of them traced to a product manufactured by Bausch & Lomb: ReNu with Moisture Loc, a contact lens cleaning solution. As of May 15, 2006 122 cases of Fusarium keratitis have been confirmed in the U.S., and healthcare researchers, including doctors at the Centers for Disease Control and Prevention, determined in August that ReNu with MoistureLoc cleaning solution is the only contact lens product known to have contributed to eye infections in contact lens wearers. Instances of personal injury related to fungal keratitis have been reported in 33 different states, and over one-third of the 164 contact lens wearers with confirmed cases of fungal keratitis required corneal transplantation to recover their eyesight.

ReNu MoistureLoc linked to possible fungal infection

In 2005 New York optometrist Arthur Epstein found that several cases of contact lenses left soaking in Bausch & Lomb’s ReNu with MoistureLoc for a week became covered with what appeared to be a fungus. Although this was an informal experiment, Dr. Epstein, who is a spokesperson for the American Optometric Association, said he has repeatedly been able to grow Fusarium and other microbes in lenses soaked for days in ReNu MoistureLoc solution. Although Dr. Epstein claims to have alerted Bausch & Lomb to his findings, Bausch & Lomb said it did not receive access to his methodology and cannot comment on unknown data. Bausch & Lomb claims its own investigation into the Fusarium outbreak, in which it added Fusarium to lenses soaked in ReNu MoistureLoc solution, did not cause the fungus to grow on lenses.

Source: Sylvia Pagan Westphal, “Bausch & Lomb Solution Recall Exposes Risks for Eye Infections,” Wall Street Journal, July 26, 2006.

ReNu MultiPlus contact lens solution may cause corneal staining

Research has shown that multipurpose contact lens solutions may cause surface damage to the eyes of contact lens wearers who use certain brands of contact lenses, damage that could make them more susceptible to infection. The phenomenon, known as “corneal staining,” can harm the cornea itself by breaking the primary barrier of defense inside the eye.

Optometrist Gary Andrasko of Columbus, OH performed tests on more than 400 wearers of five different types of contact lenses. The tests measured the levels of corneal staining among the lens wearers when cleaned with seven multipurpose solutions. Most subjects showed some minor levels of corneal staining with all the brands of solution, but two brands performed especially poorly.

Advanced Medical Options’ Complete MoisturePLUS solution produced high levels of staining, especially with Bausch & Lomb’s PureVision contact lenses. AMO has since recommended to doctors that the company’s product not be used with PureVision lenses.

Bausch & Lomb’s ReNu MultiPlus product performed worst of all, affecting an average of 73 percent of all subject’s corneal surface area with staining, even when used with the company’s own PureVision lenses.

Source: Sylvia Pagan Westphal, “Bausch & Lomb Solution Recall Exposes Risks for Eye Infections,” Wall Street Journal, July 26, 2006.

FDA recalls ReNu MoistureLoc

The U.S. Food and Drug Administration (FDA) released a statement on Monday, May 15, 2006 announcing that Bausch & Lomb, makers of the ReNu with MoistureLoc contact lens cleaning solution product that has been linked to at least 32 confirmed cases of Fusarium keratitis infection in the United States, had recalled the product worldwide.

Due to an alarming number of adverse event reports received by the FDA and the Centers for Disease Control (CDC), the FDA investigated a Bausch & Lomb facility in Greenville, SC, linked to cases of a fungal eye infection known as Fusarium keratitis, a rare bacterial infection, in the U.S., Singapore and Hong Kong. In its preliminary statement on its investigation, the FDA found 20 potential violations in the Greenville, SC, facility.

Among the most serious findings in the report was the fact Bausch & Lomb did not report to the FDA or the CDC that 35 cases of Fusarium keratitis in Singapore were confirmed as being linked to their product within 35 days, as required for products manufactured in the United States. The company had reports of problems as early as July 2005 but had not reported details to the FDA as of May 9, 2006.

The eye infection reported in these cases, a rare but extremely serious microbial keratitis caused by the fungus Fusarium, may cause personal injury and vision loss severe enough to require corneal transplants in affected individuals. Fusarium keratitis requires up to three months of treatment and may cause corneal scarring and permanent blindness.

By April 2006, over 200 cases of fungal keratitis had been reported to these federal agencies, with 73 of them traced to a product manufactured by Bausch & Lomb: ReNu with Moisture Loc, a contact lens cleaning solution. By May 15, 2006, 122 cases of Fusarium keratitis had been confirmed in the U.S., and healthcare researchers, including doctors at the Centers for Disease Control and Prevention, determined that ReNu with MoistureLoc cleaning solution was the only contact lens product known to have contributed to eye infections in contact lens wearers.

Instances of personal injury related to fungal keratitis have been reported in 33 different states, and over one-third of the 164 contact lens wearers with confirmed cases of fungal keratitis required corneal transplantation to recover their eyesight.

Sources: FDA Release, May 15, 2006, accessed May 16, 2006; Ben Dobbin, “Health Concerns Prompt Recall of Contact Cleaner,” Associated Press, May 16, 2006. ; Jon Kamp, “Contact-Lens Hygiene Problems,” Wall Street Journal, June 28, 2006; “Study documents outbreak of fungal eye infections among contact lens wearers in Singapore,” Brightsurf.com News, June 28, 2006; Wei-Boon Khor, MBBS, et. al, “An Outbreak of Fusarium Keratitis Associated with Contact Lens Wear in Singapore,” Journal of the American Medical Association 295: 24 (abstract), June 28, 2006.

Two Keratitis Lawsuits Filed Against Bausch

Two couples from Nashville, TN have filed separate personal injury lawsuits against Bausch & Lomb alleging its ReNu with MoistureLoc Multi-Purpose Solution product led to their contraction of the serious bacterial eye fungus Fusarium keratitis. ReNu with MoistureLoc was recalled in May 2006. Soon after, the Centers for Disease Control (CDC) confirmed over 180 cases of Fusarium keratitis across the U.S. linked to contact lens solutions like ReNu with MoistureLoc and ReNu MultiPlus. Bausch & Lomb may be facing as many as 700 personal injury lawsuits related to Fusarium keratitis infections and other injuries linked to ReNu with MoistureLoc. The CDC called ReNu with MoistureLoc “the potential root cause” of an outbreak of infections worldwide.

“It’s pretty conclusive that this outbreak was due to this product,” Dr. Sonsino said.

Sources: Jared Allen, “Bausch & Lomb eye infections, lawsuits, surface in Nashville,” Nashville City Paper, February 13, 2007; Ben Dobbin, “Bausch & Lomb sees 2006 revenue falling below previous guidance on slow recovery,” January 31, 2007, accessed February 13, 2007.

Do You Need A ReNu MoistureLoc Lawyer? – Free Call, No Obligation

If you or someone you love have been using ReNu with MoistureLoc MultiPurpose Contact Lens Solution and have experienced blurring, clouding of the eye’s surface, significant eye inflammation, excessive tearing, discharge from the eye, light sensitivity, eye lesions or vision loss, healthcare professionals suggest you see a physician immediately.

Contact our personal injury law firm today. A consultation with a product liability lawyer may be in your best interest. If Bausch & Lomb knew the risks of using ReNu MoistureLoc were more dangerous than it claimed, you may be entitled to compensation for the injuries you may have suffered as a result. Our lawyers are investigating the circumstances of this case. Your information will be reviewed by a lawyer who may be able to help you gain compensation from a ReNu MoistureLoc lawsuit.